VELA 16530-12Recalls & reported problems
Vyaire Medical, Inc. · VELA CF,DISS,GRN O2,TYPE K,ICON OVERLAY · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10190752153387), received between Jun 16, 2023 and Jul 16, 2024 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Failure to Calibrate” (4 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Calibrate4
- Mechanical Problem2
- Failure to Recalibrate1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED VYAIRE MEDICAL: TRANSUCER (XDCR) FAULT OCCURRED DURING USAGE ON A PATIENT. THERE WAS NOT INJURY OR HARM TO THE PATIENT. MEDICAL INTERVENTION WAS NOT REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19751972 ↗MalfunctionJul 12, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL: A TRANSDUCER FAULT OCCURRED ON THE VELA VENTILATOR DUE TO SWAPPING THE MAIN BOARD DUE TO PERSISTENT TRANSDUCER FAULTS WHILE ON A PATIENT. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19730386 ↗MalfunctionJun 17, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THE VELA VENTILATOR HAD A "TRANSDUCER FAULT." NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19547525 ↗MalfunctionMay 3, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL A TRANSDUCER (XDCR) MOTOR FAULT APPEARED WHEN THE VENTILATOR WAS POWERED ON. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19239499 ↗MalfunctionApr 8, 2024Failure to Recalibrate; Failure to Recalibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AIRWAY PRESSURE DID NOT INCREASE DURING A MAINTENANCE WORK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19059500 ↗InjuryJun 16, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAD AN XDCR (TRANSDUCER) FAULT OCCURRED DURING USAGE ON A PATIENT. THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR AND THERE WAS NO PATIENT HARM REPORTED ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17145700 ↗InjuryJun 16, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENTILATOR HAD AN XDCR (TRANSDUCER) FAULT OCCURRED DURING USAGE ON A PATIENT. THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR AND THERE WAS NO PATIENT HARM REPORTED ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17145591 ↗
Other Ventilator, continuous, facility use devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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